Subject: Caprelsa 1783-A SGM P2022a
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided that
all the approval criteria are met and the member has no
exclusions to the prescribed therapy.
A. FDA-Approved Indication
Treatment of symptomatic or progressive medullary thyroid
cancer in patients with unresectable locally advanced or
metastatic disease
Use Caprelsa in patients with indolent, asymptomatic or
slowly progressing disease only after careful consideration of
the treatment related risks of Caprelsa.
B. Compendial Uses
Follicular, Hürthle cell, and papillary thyroid carcinoma
All other indications are considered experimental/investigational
and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
Thyroid carcinoma
Authorization of 12 months may be granted for treatment of
thyroid carcinoma when any of the following criteria are met:
A. Member has follicular, Hürthle cell, or papillary thyroid
carcinoma that is not amenable to radioactive iodine (RAI)
therapy.
B. Member has medullary thyroid carcinoma.
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting authorization for an
indication listed in Section II when there is no evidence of
unacceptable toxicity or disease progression while on the
current regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Caprelsa [package insert]. Cambridge, MA: Genzyme Corporation; March 2022.
- The NCCN Drugs & Biologics Compendium © 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed August 4, 2022.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
February 17, 2023
